Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia (MgSO4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01408979
First received: August 2, 2011
Last updated: August 20, 2012
Last verified: April 2012

August 2, 2011
August 20, 2012
August 2011
December 2011   (final data collection date for primary outcome measure)
Need to continue therapy for another 12 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.
Same as current
Complete list of historical versions of study NCT01408979 on ClinicalTrials.gov Archive Site
Satisfaction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Patients satisfaction with the duration of therapy
Same as current
Not Provided
Not Provided
 
Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial

Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Severe Preeclampsia
  • Drug: Magnesium sulfate 12 hours
    Magnesium sulfate, 1g/h, (10% solution), for 12 hours
  • Drug: Magnesium sulfate 24 hours
    Magnesium sulfate, 1g/h, (10% solution), for 24 hours
  • Experimental: 12 hours of magnesium sulfate
    Patients in this group will have magnesium sulfate administered for 12 hours after delivery
    Intervention: Drug: Magnesium sulfate 12 hours
  • Active Comparator: 24 hours of magnesium sulfate
    Patients in this group will have magnesium sulfate administered for 24 hours after delivery
    Intervention: Drug: Magnesium sulfate 24 hours
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pre-eclampsia;
  • Puerperium.

Exclusion Criteria:

  • Associated maternal diseases;
  • Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
  • Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
Female
11 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01408979
MgSO4
Yes
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
Instituto Materno Infantil Prof. Fernando Figueira
Not Provided
Principal Investigator: Melania M Amorim, MD; PhD IMIP
Instituto Materno Infantil Prof. Fernando Figueira
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP